AMIA Urges HHS to Provide More Information on Common Rule Updates

The Federal Policy for the Protection of Human Subjects, otherwise known as the Common Rule, was first adopted in 1991; however, there have been numerous calls for the policy to be updated.

The purpose of the Common Rule is to provide a framework for protecting human research subjects across the entire federal government. The Common Rule was introduced at a time when research was mainly conducted at medical institutions and universities. At the time, digital data was not in use.

The past 26 years have seen considerable changes to where research is conducted, how much information is now available, how easy it is for information to be shared and for research participants to be identified.

Earlier this year, proposed Common Rule updates were published by the HHS. The Trump administration is reviewing the Common Rule updates, although at this stage it is unclear whether any changes will be made, and if so, when those changes will be implemented.

The updates were subjected to a 40-day regulatory freeze; but more than 150 days have now passed and there has been no further communication to stakeholders on the status of the Common Rule updates. It is unclear whether the proposed effective date of January 19, 2018 will be met.

The American Medical Informatics Association (AMIA) is concerned over the lack of progress and has recently voiced its concerns in a letter to the Department of Health and Human Services and the Office of Management and Budget.

In its letter, AMIA strongly encourages federal officials to keep the original effective date due to the pressing need for changes to the Common Rule, although AMIA has recommended moving the compliance date forward to June 19, 2018 to give researchers more time “to harmonize old and new provisions”.

The lack of any further information is a concern. AMIA suggests an official announcement should be made about the Common Rule updates immediately.

In the letter, AMIA says, “Over the last several years, a paradigm shift has occurred in the nature, scope and frequency of research involving human subjects, their biospecimens, and their data. Combined with rapid adoption of electronic health records (EHRs) by care providers and dramatic improvements in computing technology, we believe the final revisions to the Common Rule are necessary to improve discovery of new health insights and advance healthcare transformation.”

The Common Rule updates include new protections for individuals who choose to take part in research studies, but the updates will also reduce administrative burdens, particularly for low-risk research studies. For example, exemptions have been included when low risk studies are conducted by HIPAA-covered entities. This would also allow more secondary research of EHR data. The administrative burden is further reduced by eliminating the need for a continuous review for many studies.

The changes also allow researchers to obtain broad consent which will greatly improve availability of biospecimens and patient-reported data for secondary research. Important changes are also made to consent, requiring the most important information to be communicated to participants clearly and concisely in a way that a reasonable person would understand.

The changes will also mean potential research participants are screened more effectively, which will help identify patients who qualify for new treatments and ensure those individuals learn about their options.

AMIA President and CEO Douglas B. Fridsma, said, “Patients expect researchers to leverage their data for improved care in responsible ways. The updated Common Rule enables and encourages better transparency so that new discoveries are possible.”

Peter J. Embi, MD, MS, President and CEO Regenstrief Institute, Inc., said, “It is critical that we adopt these changes for the sake of our national research enterprise,” Embi went on to explain, “We need to know that important aspects of the finalized Common Rule will proceed as planned. Without such a clear signal, the revised Common Rule’s new benefits will be delayed, leaving in place a 26-year old rule that doesn’t serve the needs of research participants or the research community.”

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